APPRAISE: A Tool for Appraising Potential for Bias in Real-World Evidence Studies on Medication Effectiveness or Safety.

ABSTRACT:

Objectives

Real-world evidence (RWE) plays an increasingly important role in health technology assessment (HTA), as well as regulatory and clinical decision making. RWE studies, however, are subject to multiple sources of bias, which are often not easy to identify, impeding credibility and inclusion of RWE in decision making. A comprehensive, fit-for-purpose, and easy-to-use bias assessment tool would help streamline RWE evaluation, enabling efficient utilization of RWE for decision making globally.

Methods

A working group of the International Society for Pharmacoepidemiology collaborated with HTA experts to develop a tool that could guide bias assessment in observational studies on the comparative safety and effectiveness of medications, building upon existing methodologica

SUBMITTER: Bykov K 

PROVIDER: S-EPMC12392756 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature